On September 14, Curium announced that Bexlutry ([177lu]oxooctreotide, development code: PNT2003) had received FDA approval. This drug is Lutathera ([177lu]oxooctreotide), i.e., a generic version. This is the world's first approved generic radiopharmaceutical. The original drug, Lutathera, is a radioligand therapy (RLT) targeting the somatostatin receptor type 2 (SSTR2), acquired by Novartis through its acquisition of Advanced Accelerator Applications. It was first approved for marketing in the European Union in 2017. Currently, the drug is indicated for adult patients and children aged 12 years and older with unresectable or metastatic, progressive, well-differentiated (G1 and G2) SSTR-positive gastroenteropancreatic neuroendocrine tumors (GEP-NET). According to Novartis' financial report, Lutathera's global sales were $816 million in 2025. In November 2022, Lantheus acquired exclusive global rights to PNT2003 from POINT Biopharma, excluding China, Japan, South Korea, Indonesia, and Singapore. In October 2023, Eli Lilly acquired POINT Biopharma for $1.4 billion, gaining the remaining rights to the drug. This August, Curium acquired Lantheus for $8 billion. Curium filed a marketing application for Bexlutry with the FDA in 2024. That same year, it initiated litigation with Novartis over six patents (US10596276, US10596278, US11904027, US12144873, US12151003, and US12161732). In March of this year, the FDA provisionally approved Bexlutry's Abbreviated New Drug Application (ANDA). In June 2026, all six patents were invalidated, and Curium won the case. Therefore, Bexlutry's provisional approval was converted into full approval.

Source: https://mp.weixin.qq.com/s?__biz=Mzg2NjY2OTYxNw==&mid=2247634164&idx=1&sn=9141ee17af574eaf17e1cd33d709f613